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Neuromuscular Scoliosis clinical trials

View clinical trials related to Neuromuscular Scoliosis.

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NCT ID: NCT06367933 Not yet recruiting - Surgery Clinical Trials

Mini-invasive Spine Surgery for Neuromuscolar Scoliosis

MISNM
Start date: July 2024
Phase: N/A
Study type: Interventional

Neuromuscular scoliosis (SNM) are deformities related to the impairment of normal function of the central nervous system (CNS) and/or peripheral nervous system (PNS) resulting in alterations to the of the functional unit represented by the integrated motor sequence (SIM). At the level of the spine, dysfunction of the SIM results in altered dynamic support of the spine. This results in a control of the trunk that is not harmonious due to the lack of effective mechanisms of muscle compensation. In particular, a greater degree of pelvic tilt with respect to the ground plane, with an increase in the degree of the so-called pelvic obliquity (OP), a fundamental parameter in walking and maintaining the seated posture. Spinal deformity causes severe alterations of the rib cage resulting in respiratory failure that often requires ventilatory supports and is associated with frequent airway infections, including pneumonias, often fatal. SNMs also express other comorbidities: cardiac (heart failure), neurological (epilepsy), nutritional that necessitate careful management multidisciplinary and especially anesthesiological evaluation for the peri-operative management. The surgical treatment of SNM constitutes a topic that is still debated due to both the bio-mechanical peculiarities of SNM and the clinical features, particularly comorbidities, that characterize this patient population. Compared with idiopathic scoliosis surgery, in SNM there is a higher rate of complications. To date, most of the complications are respiratory in nature (23%), followed by complications mechanical of the implanted surgical instrumentation (13%), and surgical site infections (11%). Furthermore, there is evidence that SNM surgery correlates with increased blood loss intraoperative. To date, it is recognized in the literature that the safest and most effective surgical treatment for SNMs is arthrodesis posterior instrumented with pedicle screws extended to the pelvis. In the years, mini-invasive surgical techniques have become increasingly prominent. invasive with the goal of reducing operative time, blood loss and complications themselves.

NCT ID: NCT06042699 Recruiting - Anemia Clinical Trials

Scoliosis Iron Supplementation Study

Start date: January 11, 2024
Phase: N/A
Study type: Interventional

This study is a randomized controlled trial of preoperative oral iron supplementation, to identify whether iron deficiency is a modifiable risk factor for adverse surgical outcomes such as red blood cell transfusion and diminished postoperative cognitive and physical capacity in adolescents undergoing scoliosis surgery. Research Question(s)/Hypothesis(es): Primary - Iron supplementation will reduce the incidence of perioperative RBC transfusion in iron deficient scoliosis patients undergoing spinal fusion. Secondary - Iron supplementation will reduce postoperative neurocognitive functional declines in iron deficient scoliosis patients undergoing spinal fusion. - Iron supplementation will improve patient-reported physical functioning in iron deficient scoliosis patients undergoing spinal fusion.

NCT ID: NCT06023043 Not yet recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients

Start date: November 1, 2023
Phase: Phase 4
Study type: Interventional

The goal of this randomized clinical trial is to compare the immediate use of steroids after surgery for accelerated discharge in adolescent idiopathic scoliosis and neuromuscular scoliosis after a posterior spinal fusion. The main question it aims to answer are: - What are the effects of using steroids immediately after surgery in decreasing opioid use and helping early mobilization(movement)? - Does post-operative steroid use affect the incidence of wound complications and are there any long-term impacts on scar formation? Participants will: - Fill out a Patient-Reported Outcomes Measurement Information System (PROMIS) survey specifically for pain interference and physical activity observing health related quality of life at enrollment, 3 months, 1 year, and 2 years - Have clinical photos of their incision at 3 months, 1 year, and 2 years - Their photos will be assessed using the stony book scar evaluation scale - For treatment of their scoliosis, patients will undergo a posterior spinal fusion (PSF) per standard of care, however whether the participant receives or does not receive steroids is what the investigators are trying to understand. - Researchers will compare no immediate postoperative steroid (NS) to the group with immediate postoperative steroid (WS) group to see if there are changes in opioid use, wound complications, scar formation, and facilitation in early mobilization.

NCT ID: NCT05281757 Recruiting - Clinical trials for Idiopathic Scoliosis

Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Complex

COSINE
Start date: February 18, 2022
Phase:
Study type: Observational

Multicenter, multinational Post-Market Clinical Follow-Up (PMCF) study on the safety and performance of Ennovate® Complex - A prospective, pure data collection of all Ennovate® scoliosis patients in selected centers (not interventional, multicentric)

NCT ID: NCT05071144 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Spine Procedures Assisted With RoboTics And Navigation

SPARTAN
Start date: December 13, 2021
Phase:
Study type: Observational [Patient Registry]

Creation of a pediatric robotic spine surgery registry will allow for data collection and analysis on the coupled use of robotics and navigation in pediatric spine deformity surgery across participating study institutions. Eventually, an educational and informative framework for this technology will be established.

NCT ID: NCT04969770 Active, not recruiting - Clinical trials for Neuromuscular Scoliosis

Contribution of Muscle and Disc Elastography in the Evaluation of Biomechanical Modifications of the Neuromuscular Spine Fixed by Bipolar Construct

ELASTO
Start date: January 11, 2022
Phase: N/A
Study type: Interventional

Neuromuscular scoliosis are caused by a disorder of the brain, spinal cord or muscular system and often progressive at early age. Conservative treatment is not sufficient to maintain trunk and pelvic balance, and surgical treatment is frequently required. Early definitive spine fusion has the disadvantage of cessation of trunk growth with concomitant effects on lung development. Growth preserving spine surgeries are increasingly used but with high complication rates. The orthopaedic team at Necker Hospital Enfants maladies, Paris, France has developed an innovative fusionless surgery based on a bipolar spine construct, performed by a minimally invasive approach. The first 100 patients operated on with this technique had an average follow-up of 6.5 years. No arthrodesis, initially planned in adolescence, was necessary thanks to the stability of the correction of the deformities even after skeletal maturation. The main objective of the study was to analyze the progressive spinal stiffening, using muscle and disc elastography, in neuromuscular patients instrumented with this bipolar construct.

NCT ID: NCT04764812 Recruiting - Clinical trials for Neuromuscular Scoliosis

Determination of Risk Factors and Awareness Associated With Development of Neuromuscular Scoliosis

Start date: March 1, 2021
Phase:
Study type: Observational

Neuromuscular diseases caused by disruption of the normal conduction relationship between nerve system, neuromuscular junction, and muscles cause scoliosis as a secondary deformity. Neuromuscular scoliosis progresses due to muscle weakness and characteristic features of disease. The risk of complications associated with increased progression. Morbidity and mortality caused by scoliosis in neuromuscular diseases can be reduced by increasing the knowledge and awareness of the caregivers and physiotherapists. In this study, it was aimed to determine the risk of neuromuscular scoliosis and the factors which can cause in children with disabilities. It is also aimed to reveal inferences related to education levels, awareness of caregivers and professionals working in this field to determine cases with a high risk of scoliosis. Thus, it is expected to leading future research to develop preventive treatment approaches. For this purpose, 288 children who are diagnosed with the neuromuscular disease between 3-18 years of age, attending Rehabilitation Center in Istanbul and willing to participate in the research permitted by their caregiver will be included in this study. Cerebral Palsy Follow-Up Program (CPUP), Parents and Professionals Awareness Questionnaire related to Neuromuscular Scoliosis which is prepared by researchers, Early Onset Scoliosis 24 Questionnaire, Scoliosis Research Society 22 Questionnaire to assess QoL, demographic and clinical data also will collect for all sample. Patients will be examined for musculoskeletal system, scoliosis analysis will be performed radiologically. Data obtained to determine the problems, risk factors, and awareness of the caregivers and physiotherapists will be analyzed statistically.

NCT ID: NCT04021784 Completed - Clinical trials for Neuromuscular Scoliosis

Limited-efficacy Testing of SDS and NEMOST for Early Onset Neuromuscular Scoliosis

BiPOWR
Start date: May 6, 2019
Phase: N/A
Study type: Interventional

The primary aim of this study is to investigate and describe the limited efficacy of the Spring Distraction System (SDS) and Bilateral One Way Rod (NEMOST) in maintaining curve reduction without repeat lengthening procedures and complications. Secondary aims are to describe growth of the instrumented spine, health-related quality of life, and to compare both devices.

NCT ID: NCT04012112 Completed - Clinical trials for Neuromuscular Scoliosis

The Effect of Flexible Thoracolumbar Brace on Spinal Alignment, Pain and Quality of Life in Subjects With Neuromuscular Scoliosis

Start date: August 23, 2018
Phase: N/A
Study type: Interventional

In the initial evaluation, the degree of spine is measured quantitatively using Cobb's angle and Muscular Dystrophy Spine Questionnaire (MDSQ). The patients who had Cobbs angle of 20-45 'by spinal plain radiography were evaluated for the effects of flexpine brace wearing and rehabilitation for 6 months. After 12 months, whole spine X-ray was taken for the followed up the patient's status.

NCT ID: NCT03863496 Completed - Clinical trials for Neuromuscular Diseases

Efficacy of Surgical Treatment by Different Pedicle Screw Systems in Pediatric Neuromuscular Spinal Deformity

Start date: January 31, 2018
Phase: N/A
Study type: Interventional

This study was sponsored by Federal state budgetary institution "Russian scientific center for traumatology and orthopedics" n.a. acad. G.A. Ilizarov" of the Ministry of Health of Russian Federation. The study will take place at this center. It is expected to enroll 70 patients aged 6-25 years with NMD, all of whom will be subjected to thoracic and lumbar spinal deformity surgery. Patients will be divided into two groups depending on skeletal maturity. The degree of skeletal maturity will be determined on the basis of an X-ray study of spinal and pelvic bones. The type of surgical correction will depend on the group.